NCT01846299

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Conditions

• Macular Edema (ME)

Interventions

Type	Name	Description
OTHER	Sham control	The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
DRUG	Ranibizumab	Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-05-03
• Last updated: 2016-05-23
• Results posted: 2016-05-23

Locations

61 sites across 19 countries: Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Netherlands, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom